Many of you will know about orphan drugs and the assistance available from the regulatory bodies should you be awarded an orphan registration.
Applying for orphan registration is a straight forward process, however there are ways of making it even more simple. The FDA and EMEA have combined their application processes into a single form, so it is now possible to fill in a single form and submit it to both regulators.
It is possible to get twice the return for your orphan application effort. But why would you want to do this you may ask what is the benefit? There are a number of commercial benefits from obtaining an orphan registration:
- scientific assistance (get your development plan rubber stamped)
- easy development requirements (more attractive to investors)
- a chance to get some much needed publicity
- demonstrates your team have the capability to deliver in the drug development environment.
if you have any questions about orphan registration then just drop me an e-mail, damien.bove@idaconsultants.com and I will be sure to help.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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